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After clearing an FDA hurdle, Amgen wins an FDA OK on CKD drug Parsabiv

Amgen barely managed to complete a full paragraph when the pharma giant announced last August that the FDA had rejected Parsabiv (etelcalcetide) for secondary hyperparathyroidism (SHPT), a disease that affects chronic kidney disease patients on hemodialyis. But the company managed to whip up something more in-depth when it announced last night that the agency had handed over an approval.

Regularly hailed as a top late-stage drug at Amgen $AMGN, investigators tested the drug in more than a thousand patients, reportedly meeting its primary endpoints by slashing dangerously high parathyroid hormone levels. In one study 74.7% of subjects on the drug hit its target, compared to just 8.9% in the placebo arm. In another Phase III trial the new drug outperformed Amgen’s blockbuster drug Sensipar, which earned $1.4 billion.

The approval marks the first new drug for this condition in 12 years, they add.

Geoffrey A. Block

Thomson Reuters estimates that the drug should score well on the revenue side, but fall far short of a blockbuster with about $600 million in peak sales. Investors were left unimpressed, though, with the stock down slightly in early trading.

“As a physician who cares for patients with advanced chronic kidney disease, I understand the importance of achieving and maintaining simultaneous reductions in a number of complex lab values in the treatment of secondary HPT,” said Geoffrey A. Block, MD, nephrologist at Denver Nephrologists, in the company’s statement. “The ability to provide my patients with an intravenous calcimimetic and help ensure they receive the therapy they need is a tremendous milestone in the management of this frequently undertreated chronic progressive disease.”


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